None listed
Conditions
Brief summary
Artificial tear supplementation is the mainstay of treatment for dry eye disease, designed to mimic natural tears and improve the stability and properties of the tear film. Aqueous-based and lipid-containing artificial tears are the most used formulations for the treatment of dry eye, primarily due to their rapid ability to alleviate symptoms. However, there is a lack of evidence for selecting artificial tears tailored to specific dry eye disease subtypes. This study aims to investigate the comparative efficacy of aqueous and lipid-based artificial tears in improving symptoms, clinical signs, inflammatory biomarkers, and corneal immune cell dynamics of various dry eye disease subtypes.
Interventions
Hylo Forte, Novatears, and Systane Complete preservative-free artificial tear drops will be the interventions used in this clinical trial. Each has different properties to provide either an aqueous or lipid-based supplementation to the ocular surface.
Hylo Forte artificial tears contain 2 mg/mL of sodium hyaluronate as the active ingredient and citric acid, sodium citrate dihydrate, and sorbitol as the inactive ingredients. NovaTears is a lipid-based artificial tear formulated from perfluorohexy
Hylo Forte, Novatears, and Systane Complete preservative-free artificial tear drops will be the interventions used in this clinical trial. Each has different properties to provide either an aqueous or lipid-based supplementation to the ocular surface. Hylo Forte artificial tears contain 2 mg/mL of sodium hyaluronate as the active ingredient and citric acid, sodium citrate dihydrate, and sorbitol as the inactive ingredients. NovaTears is a lipid-based artificial tear formulated from perfluorohexyloctane. Systane Complete contains propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, and sorbitol. All participants will receive each intervention for three months. Participants will be randomly assigned to start one of the three interventions: Hylo Forte, Systane Complete or Novatears. They will be instructed to apply the assigned eye drops to both eyes four times a day for three months. After a two-week washout period to minimise carry-over effects, they will be crossed over, and each participant will proceed to the next assigned intervention. Participants will have a total of nine visits, with three visits scheduled during each treatment period: at baseline, one month, and three months. Participants will be provided with a physical diary to record details of artificial tear administration. The diary will include sections on the date and time of administration, the number of drops instilled, missed doses, symptoms or side effects, and any additional comments..
Systane Hydration and NovaTears preservative-free artificial tear drops will be the interventions used in this clinical trial. Each has distinct properties that provide either aqueous or lipid-based supplementation to the ocular surface. NovaTears is a lipid-based artificial tear formulated from perfluorohexyloctane. Systane Hydration is an aqueous-based preservative-free artificial tear containing sodium hyaluronate, polyethylene glycol 400, propylene glycol, hydroxypropyl guar, sorbitol, amino
Systane Hydration and NovaTears preservative-free artificial tear drops will be the interventions used in this clinical trial. Each has distinct properties that provide either aqueous or lipid-based supplementation to the ocular surface. NovaTears is a lipid-based artificial tear formulated from perfluorohexyloctane. Systane Hydration is an aqueous-based preservative-free artificial tear containing sodium hyaluronate, polyethylene glycol 400, propylene glycol, hydroxypropyl guar, sorbitol, aminomethyl propanol, boric acid, sodium borate, potassium chloride, sodium, and chloride. All participants will receive each intervention for three months. Participants will be randomly assigned to start either Systane Hydration or NovaTears eye drop. They will be instructed to apply the assigned eye drops to both eyes four times a day for three months. After a two-week washout period to minimise carry-over effects, participants will be crossed over, and each will proceed to the other intervention drop. Participants will have a total of six visits, with three visits scheduled during each treatment period: at baseline, one month, and three months. Participants will be provided with a physical diary to record details of artificial tear administration. The diary will include sections on the date and time of administration, the number of drops instilled, missed doses, symptoms or side effects, and any additional comments.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age of 18 years and above Have signs and symptoms of dry eye disease Willing to use commercially available artificial tears
Exclusion criteria
Active ocular infection, contact lens usage, intense pulse light therapy within 6 months, ocular surgery and trauma within three months, history of epilepsy or seizures, pregnancy or a plan to become pregnant within one year, and known hypersensitivity for components of Hylo Forte, Systane Complete, Novatears, fluorescein, and lissamine green dye will be excluded from the study.
Outcome results
None listed